Strategic Regulatory Affairs Professional

1 week ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 13,97,377 - ₹ 16,45,432

Global Regulatory Submission Management Expert

Job Description:

This role involves leading and supporting various clinical trial and marketing application type submissions, as well as associated global/submission content plans.

Key Responsibilities:
  • Participate in information system updates, software validation projects, and ongoing system testing.
  • Serve as point of contact between functional contributors and external partners to ensure smooth delivery of regulatory submissions to identified agencies.
  • Remain current on guidance (internal/external) and translate requirements into operational activities.
  • Represent departmental expertise on regulatory projects and regional/global workstreams.
  • Ensure procedures are in place and followed for processing incoming and outgoing regulatory documentation from a publishing perspective.
  • Contribute to the development of strategy for communicating with global health authorities.
  • Initiate, lead, and manage process development and improvement initiatives.
Required Skills and Qualifications:
  • Advanced technical and project management skills, demonstrated experience working in and leading teams.
  • Working knowledge of worldwide regulatory submissions in electronic Common Technical Document (eCTD) format, NeeS, and paper.
  • Advanced knowledge of Veeva Vault RIM and creation, maintenance, and overall management of Global/Submission Content Plans, reports, and dashboards.
  • Advanced knowledge of global, international, and emerging markets marketing application submission requirements, country specifications, and software used.
  • Advanced knowledge of eCTD, eCTD Specifications, and eCTD software used by regulatory publishing groups.
PREFERRED SKILLS:
  • Advanced knowledge of Veeva Vault RIM.
  • Expertise in regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications.
  • Strong project management skills related to regulatory projects and working across company disciplines to ensure timely delivery and operational execution of regional/multi-country submission filing plans.
Education and Experience:
  • Master's degree and 3-4 years of directly related experience OR Bachelor's degree and 4-6 years of directly related experience OR Associate's degree and 6-8 years of directly related experience OR High school diploma/GED and 8+ years of directly related experience.
PREFERRED EDUCATION AND EXPERIENCE:
  • Practical experience with submission requirements for EU, JAPAC, GCC, ZA.

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